MRI Risk Maps for Prostate Cancer Diagnosis

Overseen By Aytekin Oto, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Psychiatric disorders, Prisoners, Minors, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new software that helps doctors analyze MRI images of the prostate for better prostate cancer diagnosis. Participants will undergo an MRI scan and an MRI-guided biopsy, where doctors take small tissue samples to check for cancer. The trial seeks individuals who suspect they have prostate cancer and are already scheduled for an MRI and biopsy. The study aims to improve how doctors identify biopsy areas, potentially enhancing prostate cancer detection. As an unphased trial, it offers participants the chance to contribute to advancements in diagnostic technology that could improve prostate cancer detection.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this software is safe for analyzing prostate images?

Research has shown that MRI-guided biopsies are generally easy for patients to handle. These biopsies help doctors more accurately target problem areas in the prostate, making them more effective than standard methods. Most studies indicate they can better detect significant cancers, though side effects may include discomfort or minor bleeding.

The Risk Map Decision Support System (DSS) is a new tool under study to enhance MRI scan accuracy. Research suggests it can help doctors decide where to take a biopsy by highlighting areas that might have cancer. This tool is still being tested, but it is considered a safe addition to the biopsy process.

Both the MRI-guided biopsy and the Risk Map DSS aim to improve prostate cancer detection with minimal extra risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MRI-guided biopsy for prostate cancer diagnosis because it offers a more precise and targeted approach compared to traditional biopsy methods. While standard biopsies often involve taking tissue samples randomly from the prostate, this method uses MRI risk maps to guide the biopsy needle to specific areas of concern. This can potentially improve the accuracy of diagnosing prostate cancer, reducing the chances of missing aggressive tumors. By using advanced imaging technology, this approach can help doctors make more informed decisions about treatment, ultimately aiming for better patient outcomes.

What evidence suggests that the MRI Risk Map Decision Support System is effective for prostate cancer diagnosis?

Research shows that MRI-guided biopsies, which all participants in this trial will undergo, effectively diagnose prostate cancer. Studies have found that these biopsies significantly improve the detection and understanding of prostate cancer compared to traditional methods. Specifically, MRI-targeted biopsies are more likely to identify important cancer cases.

Additionally, the Risk Map Decision Support System (DSS), used in this trial, enhances accuracy. It has demonstrated high sensitivity, accurately identifying significant prostate cancer areas. Early results suggest that this tool can effectively guide treatment choices and improve patient outcomes. Together, these methods represent promising advancements in diagnosing prostate cancer. ^{2 3 6 7 8}

Who Is on the Research Team?

Aytekin Oto, MD

Principal Investigator

University of Chicago Medicine Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for men who are suspected to have prostate cancer or already diagnosed and referred for an MRI of the prostate. They must be able to give written consent and follow study procedures. It's not open to those under 18, prisoners, anyone previously treated for prostate cancer, or with psychiatric disorders affecting consent.

Inclusion Criteria

Voluntary written informed consent before the MRI examination

I am referred for a prostate MRI and biopsy due to suspected prostate cancer.

Exclusion Criteria

Subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher

I am unable to understand or sign the consent form.

Subjects with psychiatric disorders that affect their ability to consent for themselves will be excluded and not the entire population of patients with psychiatric disorders

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Biopsy

Participants undergo a one-time MRI and 1-2 MRI-guided fusion biopsies of the prostate

1 day

1 visit (in-person)

Follow-up

Participants are monitored for progress and outcomes over the course of the study

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Magnetic Resonance Imaging (MRI)
• Magnetic Resonance Imaging (MRI) Guided Biopsy
• Risk Map Decision Support System (DSS)

Trial Overview Researchers are testing a new software tool designed to improve the analysis of MRI images of the prostate. The goal is to see if this Risk Map Decision Support System can help diagnose prostate cancer more accurately using targeted biopsy guided by MRI.

How Is the Trial Designed?

Group I: All Participants (Single Arm) Experimental Treatment 3 Interventions

All participants in this trial will be provided with routine instructions and precaution information before starting the magnetic resonance (MRI) scan. After the MRI, participants will undergo an MRI-guided fusion biopsy of the prostate as ordered by their doctor. During this prostate MRI-guided fusion biopsy, the research team will obtain tissue from up to two additional biopsy targets selected by the Risk Map DSS tool. Ultimately, the clinical radiologist will make the final decision on the targets to be biopsied.

Magnetic Resonance Imaging (MRI) Guided Biopsy is already approved in United States, European Union for the following indications:

Approved in United States as MRI Guided Biopsy for:

• Prostate cancer diagnosis
• Prostate cancer staging
• Guiding targeted biopsy

Approved in European Union as Multiparametric MRI (mpMRI) for:

• Prostate cancer diagnosis
• Prostate cancer staging
• Risk stratification

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

Multiparametric MRI (mpMRI) accurately detected 92% of significant prostate cancer (sPCa) index lesions in a study of 120 patients who underwent radical prostatectomy, indicating its high efficacy in identifying clinically relevant tumors.

The combination of MRI fusion targeted biopsy (FTB) and saturation biopsy (SB) was found to be the most effective method, detecting 97% of sPCa lesions, outperforming both mpMRI and FTB alone, which highlights the importance of using multiple approaches for better cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiparametric Magnetic Resonance Imaging (MRI) and MRI-Transrectal Ultrasound Fusion Biopsy for Index Tumor Detection: Correlation with Radical Prostatectomy Specimen. Radtke, JP., Schwab, C., Wolf, MB., et al.[2022]

MRI-guided in-bore biopsy demonstrated a high overall prostate cancer detection rate of 80.5% in a study of 246 patients, with even higher rates of 92% for PI-RADS 5 targets, indicating its efficacy in identifying clinically significant prostate cancer (csPCa).

The study showed that biopsy results were reliable, with a low complication rate of 1.2% and good concordance between biopsy and radical prostatectomy Gleason scores, suggesting that this method is both safe and effective for prostate cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-bore MRI-guided prostate biopsy in a patient group with PI-RADS 4 and 5 targets: A single center experience. Vural, M., Coskun, B., Kilic, M., et al.[2021]

The study involving 42 men showed that using a multi-parametric MRI combined with contrast-enhanced ultrasound for targeted biopsies significantly improved the detection rate of prostate cancer compared to traditional systematic biopsies, with a cancer detection rate of 17.92% for targeted biopsies versus 6.15% for systematic biopsies.

Targeted biopsies based on mpMRI showed a higher cancer detection rate for suspicious lesions compared to those identified by CEUS, indicating that mpMRI may be more effective in guiding biopsies in patients with prior negative results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeat Targeted Prostate Biopsy under Guidance of Multiparametric MRI-Correlated Real-Time Contrast-Enhanced Ultrasound for Patients with Previous Negative Biopsy and Elevated Prostate-Specific Antigen: A Prospective Study. Jang, DR., Jung, DC., Oh, YT., et al.[2018]

Multiparametric magnetic resonance imaging (mpMRI) is essential for diagnosing prostate cancer and is recommended for use in active surveillance according to the S3 guidelines.

mpMRI combines high-resolution T2-weighted sequences, diffusion-weighted imaging, and dynamic contrast-enhanced sequences, which are crucial for structured reporting using the PI-RADS classification system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Multiparametric MRI of the prostate]. Herrmann, J., Kaufmann, S., Zhang, C., et al.[2022]

In a study of 415 men with low-risk prostate cancer on active surveillance, nearly 18% were found to have clinically significant prostate cancer (csCaP) when assessed with mpMRI and biopsy, highlighting the importance of monitoring even low-suspicion lesions.

The study suggests that using prostate-specific antigen density (PSAD) can help identify patients at higher risk for csCaP; for instance, men with PI-RADS 2 lesions and PSAD ≤0.12 could potentially avoid unnecessary biopsies, while those with PI-RADS 3 lesions and PSAD >0.1 should be informed about a significant risk of missing csCaP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical utility of MR/ultrasound fusion-guided biopsy in patients with lower suspicion lesions on active surveillance for low-risk prostate cancer. Lokeshwar, SD., Nguyen, J., Rahman, SN., et al.[2022]

Multiparametric magnetic resonance imaging (mpMRI) and mpMRI-guided biopsy are effective diagnostic tools for prostate cancer, enhancing the accuracy of detection and diagnosis.

These imaging techniques play a crucial role in clinical decision-making, helping to guide treatment options and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiparametric magnetic resonance imaging and multiparametric magnetic resonance imaging-guided biopsy in the diagnostic pathway of prostate cancer. Chaloupka, M., Apfelbeck, M., Pfitzinger, P., et al.[2021]

Multiparametric MRI (mpMRI) combined with fusion-guided biopsy has been shown to significantly improve the diagnosis of prostate cancer in both biopsy-naïve men and those with previous biopsies, supported by large prospective studies providing strong evidence.

Incorporating multivariable risk stratification alongside mpMRI enhances diagnostic accuracy, although there is still uncertainty about the extent to which systematic biopsies can be reduced or omitted in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiparametric MRI fusion-guided biopsy for the diagnosis of prostate cancer. Kesch, C., Schütz, V., Dieffenbacher, S., et al.[2019]

A systematic review of 16 studies involving 1926 men with positive MRIs showed that MRI-targeted biopsy (MRI-TBx) and transrectal ultrasound-guided biopsy (TRUS-Bx) had similar overall detection rates for prostate cancer, with sensitivities of 85% and 81%, respectively.

MRI-TBx was more effective at detecting significant prostate cancer (91% sensitivity) compared to TRUS-Bx (76% sensitivity), while also showing a lower detection rate for insignificant prostate cancer (44% vs 83%), indicating its potential for more accurate diagnosis in men with clinical suspicion of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging-targeted biopsy may enhance the diagnostic accuracy of significant prostate cancer detection compared to standard transrectal ultrasound-guided biopsy: a systematic review and meta-analysis. Schoots, IG., Roobol, MJ., Nieboer, D., et al.[2023]

Prebiopsy multiparametric magnetic resonance imaging (mpMRI) significantly improves the detection rates of total and clinically significant prostate cancer in biopsy-naïve patients, with detection rates of 55.3% and 46.0% compared to 42.0% and 35.2% in those without mpMRI.

The study involved 496 patients (215 with mpMRI and 281 without) and found that while targeted biopsies added to the mpMRI group detected some cancers, many were still identified through systematic biopsies, highlighting the importance of both methods in cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer detection rate of prebiopsy MRI with subsequent systematic and targeted biopsy are superior to non-targeting systematic biopsy without MRI in biopsy naïve patients: a retrospective cohort study. Washino, S., Kobayashi, S., Okochi, T., et al.[2018]

Multiparametric magnetic resonance imaging (mpMRI) significantly enhances the detection and risk classification of prostate cancer, especially in patients with previous negative biopsies and elevated PSA levels.

While mpMRI improves diagnostic accuracy, it may still miss smaller tumors, highlighting the need for continued advancements in imaging techniques to support safe treatment options like focal therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiparametric magnetic resonance imaging: Overview of the technique, clinical applications in prostate biopsy and future directions. Demirel, HC., Davis, JW.[2020]

This study aims to validate advanced MRI techniques for better identifying clinically significant prostate cancer (csPCa) in men with indeterminate or likely mpMRI scores, potentially reducing unnecessary biopsies.

The research will use histological analysis from biopsy and prostatectomy specimens to compare the accuracy of these advanced MRI methods against established standards, ensuring robust clinical validation before widespread use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histo-MRI map study protocol: a prospective cohort study mapping MRI to histology for biomarker validation and prediction of prostate cancer. Singh, S., Mathew, M., Mertzanidou, T., et al.[2022]

In a study of 122 men with Gleason 6 prostate cancer, transrectal prostate biopsy was found to have a significantly greater temporary negative impact on quality of life compared to prostate multiparametric MRI (mpMRI), with quality of life scores of 0.82 versus 0.95, respectively.

The most notable difference in health impact was related to intraprocedural pain, where biopsy patients reported much higher pain levels than those undergoing mpMRI, indicating that mpMRI may be a safer and less painful option for monitoring prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporary Health Impact of Prostate MRI and Transrectal Prostate Biopsy in Active Surveillance Prostate Cancer Patients. Shankar, PR., Maturen, KE., George, AK., et al.[2020]

The addition of MRI-targeted biopsy (MRI-TB) to standard biopsy methods significantly increases the detection of Gleason score upgrades in low-risk prostate cancer patients undergoing Active Surveillance, with improvements noted in both confirmatory and follow-up biopsies.

Using multiparametric MRI (mpMRI) to triage patients for biopsy can be beneficial, but the best approach is to combine MRI-TB with standard biopsy for those with positive mpMRI results, as this combination maximizes upgrade detection compared to using standard biopsy alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of multiparametric magnetic resonance imaging (mpMRI) in active surveillance for low-risk prostate cancer: a scoping review on the benefits and harm of mpMRI in different biopsy scenarios. Chiam, K., Carle, C., Hughes, S., et al.[2023]

A systematic review of 10 studies involving 2,192 participants found that multiparametric MRI (mpMRI) and MRI-guided biopsy for diagnosing prostate cancer are associated with fewer adverse outcomes, such as urethral bleeding and urinary tract infections, compared to traditional transrectal ultrasound biopsy.

The studies primarily focused on physical patient-centered outcomes, indicating a need for more research on the emotional and social impacts of these diagnostic tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Outcomes From Multiparametric MRI and MRI-Guided Biopsy for Prostate Cancer: A Systematic Review. Merriel, SWD., Hardy, V., Thompson, MJ., et al.[2021]

In a study of 78 men with non-suspicious multiparametric MRI results, 92.3% had no cancer detected in subsequent biopsies, indicating a high negative predictive value for mpMRI in ruling out significant prostate cancer.

Among the few cases where prostate cancer was found (7.7%), the majority were classified as indolent, suggesting that non-suspicious mpMRI can effectively identify patients at low risk for aggressive disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between non-suspicious MRI and insignificant prostate cancer: results from a monocentric study. Renard-Penna, R., Roupret, M., Compérat, E., et al.[2018]

Citations

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Multiparametric-MRI in diagnosis of prostate cancer - PMC Multiparametric-magnetic resonance imaging (mp-MRI) has shown promising results in diagnosis, localization, risk stratification and staging of clinically ...

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MRI-Targeted or Standard Biopsy in Prostate Cancer ... Outcomes. The primary outcome was the probability of detection of clinically significant prostate cancer, defined as the percentage of participants in each ...

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Evaluating Biparametric Versus Multiparametric Magnetic ... Our results demonstrate that biparametric MRI (bpMRI) is noninferior to multiparametric MRI (mpMRI) in diagnosing clinically significant prostate cancer, as ...

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Patient-Centered Outcomes From Multiparametric MRI and ... This systematic review aims to summarize and compare the current evidence relating to PCOs for mpMRI or MRI-guided biopsy as a diagnostic test ...

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Oncological Safety of MRI-Informed Biopsy Decision ... Findings In this cohort study involving 593 biopsy-naive men, 48% had negative MRI results, 86% of whom avoided biopsy over 3 years. After 3 ...

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Oncological Safety of MRI-Informed Biopsy Decision ... In this cohort study involving 593 biopsy-naive men, 48% had negative MRI results, 86% of whom avoided biopsy over 3 years. After 3 years of ...

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Dynamic Contrast-Enhanced MRI for the Detection of Prostate ... The purpose of this study was to systematically review and meta-analyze dynamic contrast-enhanced MRI (DCE-MRI) for the detection of prostate cancer.